Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-01 @ 4:38 AM
Study NCT ID:
NCT00925106
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Of Celecoxib Test Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf, AUCt, Cmax', 'timeFrame': '1.5 month'}, {'measure': 'Visual inspection of median plasma concentration versus time profiles resulting from each formulation', 'timeFrame': '1.5 month'}], 'secondaryOutcomes': [{'measure': 'Tmax, half-life', 'timeFrame': '1.5 month'}, {'measure': 'adverse events, laboratory tests, vital signs', 'timeFrame': '1.5 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability, pharmacokinetics, celecoxib'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191355&StudyName=Pharmacokinetics%20Of%20Celecoxib%20Test%20Formulations', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female volunteers\n* Body weight BMI 17.5-30.5\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease\n* Positive urine drug screen'}, 'identificationModule': {'nctId': 'NCT00925106', 'briefTitle': 'Pharmacokinetics Of Celecoxib Test Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A3191355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Celebrex capsule', 'description': 'Commercial capsule', 'interventionNames': ['Drug: Celebrex capsule']}, {'type': 'EXPERIMENTAL', 'label': 'D1', 'description': 'Test formulation D1', 'interventionNames': ['Drug: Test formulation D1']}, {'type': 'EXPERIMENTAL', 'label': 'D2', 'description': 'Test formulation D2', 'interventionNames': ['Drug: Test formulation D2']}, {'type': 'EXPERIMENTAL', 'label': 'D3', 'description': 'Test formulation D3', 'interventionNames': ['Drug: Test formulation D3']}], 'interventions': [{'name': 'Celebrex capsule', 'type': 'DRUG', 'description': 'Single dose 200 mg commercial Celebrex capsule', 'armGroupLabels': ['Celebrex capsule']}, {'name': 'Test formulation D1', 'type': 'DRUG', 'description': 'Single dose 150 mg celecoxib as formulation D1', 'armGroupLabels': ['D1']}, {'name': 'Test formulation D2', 'type': 'DRUG', 'description': 'Single dose 150 mg celecoxib as formulation D2', 'armGroupLabels': ['D2']}, {'name': 'Test formulation D3', 'type': 'DRUG', 'description': 'Single dose 150 mg celecoxib as formulation D3', 'armGroupLabels': ['D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511-5473', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}